CLASS II ONGOING Drug recall · Reported 26 Aug 2026 · FDA Enforcement Report
Pemrydi RTU(pemetrexed injection), 500 mg/ (10 mg/mL) recalled
Shilpa Medicare is recalling Pemrydi RTU(pemetrexed injection), 500 mg/ (10 mg/mL), Single-dose vial, distributed nationwide in the US. The recall was initiated on 29 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0765-2026
- FDA event ID
- 99530
- Recalling firm
- Shilpa Medicare, Jadcherla, Mahabubnagar District
- Brand
- Pemrydi Rtu
- Manufacturer
- Amneal Pharmaceuticals LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jul 2026
- FDA classified
- 14 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Jul 2026 | Recall initiated by company | |
| 14 Aug 2026 | Classified by FDA | +16 days |
| 26 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Product as listed by the FDA
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Which lots are affected?
Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99530This product is part of a recall event; the main page for the event is Pemrydi RTU (pemetrexed injection), 100 mg/ (10 mg/mL) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pemrydi RTU (pemetrexed injection), 100 mg/ (10 mg/mL) recalledPemrydi Rtu | Shilpa Medicare | Other | Nationwide |
More recalls from Shilpa Medicare
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pemrydi RTU (pemetrexed injection), 100 mg/ (10 mg/mL) recalledPemrydi Rtu | Shilpa Medicare | Other | Nationwide |
| Drug | CLASS II | Imatinib Mesylate Tablets 100 mg recalled by Shilpa MedicareImatinib Mesylate | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Busulfan Injection 60 mg/ (6 mg/mL) recalled by Shilpa Medicare | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Docetaxel Injection USP 160 mg/ (20 mg/mL) recalled by Shilpa Medicare | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Azacitidine for Injection 100 mg/vial, For Subcutaneous recalled | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
Other Pemetrexed Disodium recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pemrydi RTU (pemetrexed injection), 100 mg/ (10 mg/mL) recalledPemrydi Rtu | Shilpa Medicare | Other | Nationwide |